Illingworth 1959.

Methods	Randomised, double‐blind, cross‐over trial
Participants	Sample size: 20 infants, but 4 infants did not have the inert substance, and 1 did not have the active drug Setting: well‐baby clinic at Jessop Hospital, Sheffield Mean age: not reported (SD not reported); range not reported. Simply states that all infants were younger than 8 weeks Mean weight: not reported Mean duration of colic: not reported Mean crying: not reported Feeding: not reported Birth order: not reported Inclusion criteria: Condition for inclusion into the study was the mother's statement that screaming continued unabated when the baby was picked up. Diagnosis was based on rhythmical attacks of screaming in the evening. Exclusion criteria: not specified
Interventions	Intervention (20 infants): dicyclomine hydrochloride, half teaspoon (approximately 5 mg) before the 6 PM feed Control (16 infants): placebo, half teaspoon (approximately 5 mg) before the 6 PM feed Administration: The doctor prescribed dicyclomine hydrochloride, and the pharmacist dispensed dicyclomine or inert substance by random sampling. After 1 week, the medicine was prescribed again, and the pharmacist gave the opposite of what she had given before. Only the pharmacist knew which material (drug or placebo) the child had received. Duration of the study: 2 weeks Washout period: no information
Outcomes	The child was seen 1 week after the start of treatment, and the mother's word about colic was reported. Results were graded from '‐ 3' to '+ 3' as follows: '+ 1' child slightly better, '+ 2' definitively better but still with some discomfort, '+ 3' infant with very great improvement and free from symptoms, '‐ 1' infant slightly worse
Notes	Country: England Funding source: Study authors did not specify whether they had received financial support for the study; drug and placebo were supplied by the company, Merrell National (UK).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: No information about random sequence generation was reported.
Allocation concealment (selection bias)	Low risk	Comment: Pharmacist dispensed dicyclomine or an inert substance by random sampling.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: Parental blinding was performed. Only the pharmacist knew which material the child had received.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: Parental and paediatrician blinding was performed. Only the pharmacist knew which material the child had received.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: Four infants did not have the inherited substance, and 1 did not have the active drug.
Selective reporting (reporting bias)	High risk	Comment: Study authors did not report the results of each study period by treatment group (dicyclomine or placebo).
Other bias	Unclear risk	Comment: No information about washout period was reported.